ISO 9001: Understanding the Process Approach

A common misconception is to think you have to create documentation that follows the outline of the standard and create a procedure for every requirement. It is not uncommon to see documentation that uses the exact same numbering system and contains procedures that are in lockstep with the requirements. Templates that parallel the outline of the standard are available, which tends to reinforce this misconception.This approach to structuring a system, however, is clearly not the intent of the authors of the standard, and the problems resulting from this mindset may be the single leading cause of failed and under-performing systems. The introduction of the ISO 9001 standard states that: "It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation”. It also states that every system is "influenced by varying needs, particular objectives, the products provided, the processes employed, and the size and structure of the organization." The standard recognizes that every operation is different and that uniform documentation is not appropriate. There is no process list and no procedure list anywhere to be found in the standard, and nowhere in the standard is it suggested that you should use the outline of the standard as a basis for identifying processes or developing procedures. To do so limits the scope of the system because it removes the need for thinking about the processes that are unique to your operation, it bogs down the implementation process because it causes you to design procedures around requirements rather than developing procedures that accommodate your particular needs, and it makes writing procedures more difficult. Compliance to many of the requirements can involve many different processes. Condensing them into one procedure that complies with the needs of a given requirement is difficult and can result in procedures that are awkward and hard to follow.A better approach, and the one recommended by the authors (refer to section 0.2 of the introduction), is to build the documentation around the processes that govern how you manage the needs of your particular business. It is a “process approach”, and the key to understanding how this works starts with an understanding of the meaning of a process as it relates to the standard, which is not as straightforward as it sounds.The standard defines a process as: "An activity using resources, and managed in order to enable the transformation of inputs into outputs." The implications are there but the explanation is less than crystal clear. It’s one of the confusing aspects of the standard. I suggest that the criteria used to define the inputs and outputs also define the processes, and in turn group the procedures. For example, the criteria for the inputs and outputs of the human resource process may be: Input = Rules for making sure employees are informed and capable of performing the assigned responsibilities Output = Capable, competent, trusted, and motivated employees The criteria used to define the process of managing the infrastructure may be describes as: Input = Rules and policies for managing the tangible assets used to support the business Output = Fewer disruptions, a better working environment resulting in fewer mistakes, better efficiency, better throughput, and more satisfied customers Policies and procedures that affect such things as hiring, training, and performance management would be part of the human resource process. Housekeeping, machinery maintenance, network maintenance, and the maintenance of measuring devices would be part of the infrastructure process. A process could have one or it could have many different policies and procedures.The authors of the 9001 standard explain the "process approach" as: "The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management." My interpretation of the "process approach" is to think in terms of a common objective for a set of different processes. An objective might be the continual improvement of the management system, which is what is used in the illustration shown in the standard; or an objective might be the growth and profitability of the organization. The process approach is how the various processes interact with one another to bring about the objective. It is also an explanation that is consistent with the example illustrated in the ISO 9001 Standard. Structuring systems based on this interpretation of the "process approach" result in systems that are more personal, flexible, and easier to develop. You’re not handcuffed by the outline of the ISO Standard, and you're not limited by the requirements of the standard. You establish processes that represent the particular needs of your operation and develop the policies and procedures that bring about the desired output of these processes. Then you make sure these policies and procedures accommodate all of the requirements of the ISO 9001 Standard. The system documentation complies with all of the requirements but looks nothing like the standard.

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